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Effects of Continuous ESP Catheters on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery

Primary Purpose

Post Operative Pain, Spine Surgery

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Placebo
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post Operative Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18-80
  • Presenting for elective multilevel (>2 spinal levels) spinal fusion
  • Lumbar, thoracic, and thoracolumbar procedures included
  • Posterior surgical approach
  • Willing and able to follow the study protocol
  • Able to provide informed consent

Exclusion Criteria:

  • Opioid tolerance (more than 60 morphine milliequivalents daily for more than 3 months)
  • Daily gabapentin/pregabalin use for longer than 3 months
  • Prior spine surgery at the index level
  • Allergy or contraindication (including renal, liver disease) to included study medications
  • Patient refusal

Sites / Locations

  • Hospital for Special SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ESP Catheters with Ropivacaine 0.2%

ESP Catheters with Saline Solution

Arm Description

Outcomes

Primary Outcome Measures

Number of patients who require escalation to (ie, a new prescription for) an opioid-iv-patient controlled analgesia (iv-PCA)

Secondary Outcome Measures

Duration of use and dose of opioid-iv-pca (if required)
Measured in morphine equivalents daily
Post-operative opioid consumption
Measured in morphine equivalents daily
Numeric rating scale (NRS) pain scores: every 8 hours
Scale of 0-10, 0 being no pain, 10 being the worst pain possible
Quality of Recovery 15 (QoR15) scores
The Quality of Recovery 15 (QoR15) is a 15-item questionnaire which assesses five domains of patient-reported health status: pain, physical comfort, physical independence, psychological support and emotional state. It has a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).
Duration of ESP catheter(s) use and reasons (if any) for catheter failure or dislodgement
Measured in days after placement
Total dose of ropivacaine delivered
Measured in mg/kg/hr
Opioid-related side effects (nausea, vomiting, anti-emetic medication administration, constipation, sedation, administration of naloxone)
If the patient ever had any of the events
Length of hospital stay
Measured in days after surgery
Patient satisfaction scale with pain management and ESP catheters
Patient satisfaction will be assessed using a 0 to 10 scale (0 being not satisfied to 10 being totally satisfied)
Incidence of ongoing pain and opioid consumption, measured at 3 and 6 months post-surgery
Measured with a 7-item questionnaire to assess chronic pain and opioid use

Full Information

First Posted
July 15, 2022
Last Updated
June 16, 2023
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT05494125
Brief Title
Effects of Continuous ESP Catheters on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery
Official Title
Effects of Continuous Erector Spinae Plane Blocks on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery: A Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Single-shot erector spinae plane (ESP) blocks (ESPB) are emerging as an intervention to improve pain and minimize opioid consumption after lumbar spine surgery. Although promising, there is minimal evidence to support routine use, and widespread clinical adoption may be limited to centers with advanced regional anesthesia resources and expertise. Continuous ESP catheter techniques may solve these problems but are associated with challenges of their own. This trial will investigate the role of adding surgeon-placed, continuous ESP catheters to single-shot ESPBs for patients undergoing multilevel spine surgery. It will assess whether adding ESP catheters with ropivacaine infusion for 48 hours after surgery offers opioid-minimizing analgesia and improves patient quality of recovery, compared to ESP catheters with saline/placebo infusion for 48 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Spine Surgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESP Catheters with Ropivacaine 0.2%
Arm Type
Experimental
Arm Title
ESP Catheters with Saline Solution
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Ropivacaine
Intervention Description
Patients will receive a continuous infusion of ropivacaine through bilateral ESP catheters
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Patients will receive a continuous infusion of saline solution through bilateral ESP catheters
Primary Outcome Measure Information:
Title
Number of patients who require escalation to (ie, a new prescription for) an opioid-iv-patient controlled analgesia (iv-PCA)
Time Frame
First 72 hours after surgery
Secondary Outcome Measure Information:
Title
Duration of use and dose of opioid-iv-pca (if required)
Description
Measured in morphine equivalents daily
Time Frame
First 72 hours after surgery
Title
Post-operative opioid consumption
Description
Measured in morphine equivalents daily
Time Frame
From PACU arrival to 72 hours post surgery
Title
Numeric rating scale (NRS) pain scores: every 8 hours
Description
Scale of 0-10, 0 being no pain, 10 being the worst pain possible
Time Frame
Between PACU and 72 hours post surgery
Title
Quality of Recovery 15 (QoR15) scores
Description
The Quality of Recovery 15 (QoR15) is a 15-item questionnaire which assesses five domains of patient-reported health status: pain, physical comfort, physical independence, psychological support and emotional state. It has a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).
Time Frame
Pre-operative, holding area/day of surgery, 24 hours, 48 hours, 14 days and 42 days post surgery
Title
Duration of ESP catheter(s) use and reasons (if any) for catheter failure or dislodgement
Description
Measured in days after placement
Time Frame
First 48 hours post surgery
Title
Total dose of ropivacaine delivered
Description
Measured in mg/kg/hr
Time Frame
First 48 hours post surgery
Title
Opioid-related side effects (nausea, vomiting, anti-emetic medication administration, constipation, sedation, administration of naloxone)
Description
If the patient ever had any of the events
Time Frame
First 48 hours post surgery
Title
Length of hospital stay
Description
Measured in days after surgery
Time Frame
From PACU arrival to hospital discharge, up to 2 weeks
Title
Patient satisfaction scale with pain management and ESP catheters
Description
Patient satisfaction will be assessed using a 0 to 10 scale (0 being not satisfied to 10 being totally satisfied)
Time Frame
First 72 hours, 14 days, and 42 days post surgery
Title
Incidence of ongoing pain and opioid consumption, measured at 3 and 6 months post-surgery
Description
Measured with a 7-item questionnaire to assess chronic pain and opioid use
Time Frame
3 and 6 month post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-80 Presenting for elective multilevel (>2 spinal levels) spinal fusion Lumbar, thoracic, and thoracolumbar procedures included Posterior surgical approach Willing and able to follow the study protocol Able to provide informed consent Exclusion Criteria: Opioid tolerance (more than 60 morphine milliequivalents daily for more than 3 months) Daily gabapentin/pregabalin use for longer than 3 months Prior spine surgery at the index level Allergy or contraindication (including renal, liver disease) to included study medications Patient refusal
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen M Soffin, MD, PhD
Phone
212-606-1036
Email
SoffinE@HSS.edu

12. IPD Sharing Statement

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Effects of Continuous ESP Catheters on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery

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